Field of the Invention
The current invention relates to an adjustable mandibular advancement device which by virtue of an incremental (stepwise) mechanism, advances or withdraws the mandibular relative to the maxilla in order to prevent or reduce Snoring and/or Obstructive Sleep Apnea Syndrome (OSAS) during sleep. The adjustability is accomplished by the intrinsic embedded mechanism in the two members in conjunction or separately in either of the members relative to the other.
Background of the Invention
Snoring and Obstructive Sleep Apnea are generally known today as the same disease on a continuum of the sleep disorder severity scale. Starting at the modest degree of snoring ending in the fulminate obstructive sleep apnea condition, is known as a fact.
As the disease is closely related to a large variety of physical and mental conditions, treatment is of outmost importance as soon as possible.
Whereas the snoring condition is characterized by the sounds developed by vibrating tissues in the most dorsal area of the pharynx, either the nasopharynx, or the orophalynx or the laryngopharynx, the obstructive sleep apnea is characterized by actual respiration arrest caused by occlusion of the pharyngeal airways.
Apnea appears when the upper airway passages are being sucked close to the rear part of the throat when the person is trying to breathe during sleep. The occlusion can be the result of suction or by the lapse of tonus in the oral soft tissues during the relaxed sleep condition.
When the occlusion is there, no air is passing through the pharynx and down to the lungs, and this is the situation called OSAS (Obstructive Sleep Apnea Syndrome).
The obstruction can happen as often as 1000 times during the night time sleep in which the body is depraved from oxygen uptake from the air into the blood stream, which eventually leads to the aggravated symptoms.
The severity of OSAS has been described in the medical literature numerous times giving cause to a number of symptoms and diseases:                General headache        High blood pressure        Diabetes        Hypoxic pulmonary vasoconstriction        Cardiomyopathy        Pulmonary hypertonia with cor pulmonale (increased        pressure in the heart-lung circuits)        Heart failure, heart arrhythmia, heart attack        Day time melancholy or depression        Intelligence alterations        Acid Reflux (GERD—Gastro Esophageal Reflux Disease)        Potency disturbances        
Worsening of ADHD (Attention deficit hyperactivity disorder), in addition to a large number of problems of a more social character, like, e.g., divorce, decreased labour activity, difficulties in keeping conversations in the track due to tiredness, etc.
Thus, compared to a normal control group without diseases, patients suffering from snoring and/or OSAS appear to have: three times as many cases of coronary heart diseases, four times as many cerebral illnesses, such as clots, twelve times as many incidents of car accidents and twice as many labour accidents due to day time sleepiness as a result of lack of sleep and/or impaired sleep quality.
Due to these conditions the life time expectancy is severely limited for these patients, and their quality of life is compromised.
The continuum of snoring diseases gives the following frequency figures:                40% of adults over 40 snore (approx. 87 million Americans)        9% of men and 4% of women suffer from some form of OSAS (approx. 30 million Americans)        Less than 10% of OSA sufferers have been diagnosed (Approx 3 million Americans)        
Of those, less than 25% have been successfully treated.
For the above reasons, it is important to provide devices to eliminate and prevent apnea and the incipient stages thereof.
In the prior art, a number of surgical techniques for removal of the tissue involved in the obstruction have been developed, but all of these techniques seem to incur a certain invalidation of the patient and, at the same time, do not have a fully predictable effect.
Furthermore, a number of medical treatments have been tried out with predominantly deficient or sometimes even damaging effect.
Finally, the scientific literature and the patent literature disclose numerous devices for alarming the snoring patient during sleep; devices for tongue thrust, devices for forward movement of the soil palate; devices for obstructing the oral cavity (delimited by the lips), thereby engaging the sound from the snoring; furthermore, mandibular advancement, splints or appliances, mouth guard-like devices for provocation of either tongue, hyoid bone or jaw position changes, thereby eliminating snoring;—all of these requiring active participation from competent professionals, such as medical doctors, dentists, etc. Among such prior art devices for or attempts to inhibit snoring, the following are of particular interest in the present context:
EP 0 794 749 B1 to Ingemarsson-Matzen & Voss discloses a jaw position-regulating oral device for preventing snoring and obstructive sleep apnea during sleep. The device consist of two members, a first member to engage with the maxillary dentition and a second member to engage with the mandibular dentition, both connected by a resilient hinge. The mechanism is embedded in the mandibular advancement relative to the maxilla.
WO 2013 032 884 A1 to Fallon & Jung discloses a mandibular advancement device with an upper and lower member to engage the maxillary and mandibulary dentition respectively. The lower tray assembly is mated to and slidable adjustable by the patient relative to the upper tray assembly.
WO 2009 062 541 A1 to Magning & Magnin discloses a mandibular advancement orthosis in which the device the comprises a unitary flexible member that can be folded on itself for interaction with the teeth of the upper and lower arches, and an interchangeable flexible strip for surrounding the teeth of the upper arch, having a length that can be modified in order to obtain the desired level of mandibular advancement.
US 2009 0014 013 A1 to Magnin discloses a mandibular advancement splint made of two thermoform thermoformable trays designed to envelop the upper and lower arch. The advancement splint includes an articulated frame hazing rigid and flexible elements immersed in the thermoformable flexible material or molded around it.
EP 1 719 481 A1 to Arni discloses a mandibular advancement device with a lateral link incorporated into a mandibular protrusion device comprising an upper dental tray and a lower dental tray so as to advance or retract the lower dental arch during a vertical movement between the two. The link is adapted to be detachably accommodated in an opening of a ball pivot.
EP 2 529 710 A1 to Ash discloses a device for mandibular advancement in which an upper member and a lower member are interconnected by means of pivotal connection in which at least one is formed as a stud.
CA 223 650 3 A1 Frantz & Frantz discloses a mandibular advancement device which uses elastic bands to pull the jaw forward. The upper part having a set of retention hooks and the lower part having a set of interchangeable slide-in posterior occlusal bite planes.
WO 2008/130 413 A1 to Meade discloses a mandibular advancement device for pulling the lower jaw forward composed of an upper and a lower member to engage the dentition, where a ball type of hook support is located on both sides of the upper tray at a forward position and a ball type of hook supports are located at a rearward position of both sides of the lower jaw. A tension coil is attached to each of the upper and lower ball type of hook supports.
US 2013/001 4765 A1 to Meade discloses a mandibular advancement device for pulling the lower jaw forward composed of an upper and a lower member to engage the dentition, where a ball type of hook support is located on both sides of the upper tray at a forward position and a ball type of hook supports are located at a rearward position of both sides of the lower jaw. A tension coil is attached to each of the upper and lower ball type of hook supports.
WO 2011/115 962 A1 to Van Dyke & Tucker discloses a mandibular advancement splint made of two trays designed to envelop the upper and lower arch. The upper appliance has a pair of adjustable wings attached to the body, and the lower has a pair of fixed wings attached to the body. The upper wings are slidable adjustable.
US 2010 004 380 5 A1 to Kelly discloses a mandibular advancement device with an upper and lower member to engage with the dentition of the human. The lower dental plate having two pairs of spaced apart pillars and two removable attachable horizontal displacements inserts on the upper part.
GB 2 264 868 to Mateljan discloses an anti-snoring device for oral use, comprising members having upper and lower surfaces which engage the user's maxillary and mandibular dental arches respectively. The upper and lower surfaces are spaced so that the mandible is placed in a forwardly offset position relative to its normal position. The spacing also tensions the masticatory muscles to maintain the device in place.
US 2011/001 722 0 A1 to Lindsay et al. discloses a self-titratable mandibular repositioning device that allows for adjusting the maintained forward position by simply biting-down to preserve the desired degree of mandibular advancement, made of a lower and an upper member to engage the dentition.
US 2008 011 579 1 A1 to Heine discloses a mandibular advancement device with an intraocclusal removable device in the form of a “U” that is placed covering all of the upper jaw teeth, wherein two steps, one in each extreme of the lower part of the element, which impede the mandible be closed completely on its normal occlusion, forcing it to produce a forward displacement of the lower jaw.
US 2005 023 600 3 A1 to Meader discloses a mandibular advancement device as a single piece of molded plastic with said unit modeled from four theoretical positions including a shield like anterior portion fitted and anchored between anterior teeth-gums and behind the lips.
US 2010/030 045 8 A1 to Stubbs et al. discloses a mandibular advancement device with an upper and lower member to engage with the dentition of the human. The members are including a cam associated with one of the jaws and a follower associated with the other jaw.
US 2008/009 902 9 A1 to Lambera discloses a mandibular advancement device composed of a maxillary main body for removable attachment to the maxillary teeth with a protrusive element extending from the central portion of the body and a mandibular removable appliance attached to the mandibular anterior teeth.
EP 2 491 901 A1 to Garcia Urbano discloses regulatable intraoral mandibular advancement device for preventing snoring and sleep apnea in which a screw system is located in the central part of the connection between the upper and lower members for the engagement of the dentition.
AU 1999 476 15 B2 to Palmisano discloses a mandibular advancement device in which the upper jaw is firmly fitted into an upper plate and the lower jaw is firmly fitted into a lower plate, these two parts are connected by means of opposing flange components located to be lying in an area and close to the posterior teeth.
US 2013/001 476 5 A1 to Meade discloses a tongue and mandibular advancement device in which an upper member has hook supports anteriorly and a lower member has a plurality of hook support at the rearward position.
EP 0 337 201 to Bergersen discloses an orthodontic appliance comprising a first member to engage with the mandibular dentition and a second member to engage with the maxillary dentition. The two members are resiliently hinged together to keep the upper and lower jaw in a normal position.
WO 92/11827 to Shapiro et al. discloses an anti-snoring device for oral use consisting of a horseshoe-like upper jaw member for engaging the maxillary dentition, with the downward extending flange intended to extend into the lingual vestibule in order to maintain a forward posture of the lower jaw.
EP O 312 368 to Hays discloses an anti-snoring device for oral use which resembles the above-mentioned device, the main difference being the design of the airway passage.
WO 92/05752 to Wu discloses an anti-snoring device for oral use consisting of a spatial member congruent with the palate and a lower member adapted to the lingual aspects of the surfaces of the dentition in the lower jaw, hooks being attached to the occlusive plane of the device for fixing the two jaws in a predetermined relation.
U.S. Pat. No. 5,313,960 to Tomasi discloses an anti-snoring device for oral use consisting of two horseshoe-like individually shaped mouthpiece portions which are connected and fixed in a predetermined position in which the lower jaw protrudes in relation to the upper jaw.
U.S. Pat. No. 7,910,502 B1 to Nguyen & Nguyen discloses an anti-snoring device for oral use consisting of two horseshoe-like individually shaped mouthpiece portions which are connected and fixed by an assembly of tubes, hooks and screws to be attached to the two separate members. The main difference from the present patent application is that the device is using detachable screws, spring coils and loops to keep the mandible in a forward position, meaning that there is no intrinsic resilient hinge. Therefore the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow.
DE 201 02 432 U1 Trentepohl et al. discloses an anti-snoring device for the oral use comprising an upper and lower member to engage with the maxillary and mandibulary dentition interconnected by an adjustable telescopic device which is attached at the outer surface of the members. The main difference from the present patent application is that the device is using detachable telescopic devices to keep the mandible in a forward position. Thus the device lacks the intrinsic resilient hinge. Also the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow.
WO 21013 049 751 A2 to Rogers discloses a method for use in connection with sleep-disordered breathing, of forming oral orthotic systems to position and or stabilize a mandible of a patient includes providing an upper dental member adapted to be placed in connection with upper dentition of the patient, providing a lower dental member adapted to be placed in connection with lower dentition of the patient providing a plurality of posterior mounting structures. Each of the posterior mounting structures is adapted to be attached to one of the upper dental member or the lower dental member at a posterior, buccal position thereon. Each of the posterior mounting structures includes a plurality of positions at which one of the pluralities of connectors is attachable to the extending member. Force may be applied to the mandible of the patient via at least one of a plurality of different mechanisms via attachment of a component of the mechanism to at least one of the posterior mounting structures. The upper dental member and the lower dental member are formed, independently, from at least one polymeric material. The main difference from the present patent application is that the device is using multiple detachable mounting structures to keep the mandible in a forward position. Thus the device lacks the intrinsic resilient hinge. The upper and lower members are constructed after direct impressions of the user's teeth, and then separately in a second laboratory procedure casts the hard polymeric (acrylic) material to form congruent trays for the upper and lower jaws. As this system is using hard acrylic material it substantially differ from the present patent application in function, durability and comfort. This gives a disadvantage in regard to monetary price for the end user. Also the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow.
US 2013 009 837 2A1 to Webster et al. discloses an oral appliance for prevention of sleeping problems, including snoring, sleep apnea and bruxism. Specifically the device alters the position of the mandible and is made of a one piece device molded from a flexible polymer. Both upper and lower dental trays include inner and outer walls which increase contact area with the teeth. The hinge mechanism of the device includes a positive positioning system comprised of upper and lower opposed interlocking ridges. The ridges serve to create offset between the position of the upper and lower tray relative to each other, therefore advancing the user's mandible. The main difference from the present patent application is that the device is a one-piece device folded on a fixed point in the back most posterior part of the device to keep the mandible in a forward position. The interlocking ridges keep the lower and upper trays in a fixed forwarded position, thereby merely prohibits the other vice rolling possibility of the device leading into misuse of the intention of the device. Also there is no kind of incremental adjustability. Hence there is no individualization possibility.
US 2011 022 626 1A1 to Hernandez discloses a mouthpiece for reducing snoring. The mouthpiece includes an upper guard configured to lit over the upper teeth of the user, a lower guard configured to fit over the lower teeth of a user, a spacer assembly provided between the upper guard or the lower guard to provide an air passage at the middle section of the mouthpiece, a first adjustable assembly attached to the left side of the upper guard and the left side of the lower guard, and a second adjustable assembly attached to the right side of the upper guard and the right side of the lower guard. The first adjustable assembly and the second adjustable assembly are operable to move the lower guard relative to the upper guard. The main difference from the present patent application is that the device is using detachable blocks and screws devices to keep the mandible in a forward position. Although the device depicts a kind of hinge (flexible coplanar connectors), this hinge is merely decided for avoiding sharp edges at the posterior part of the two members and for ease and economy of manufacture, and can not function as an actual durable active hinge due to the fact that the screws in the blocks are rigid. In conclusion, the device is much more complicated and technical demanding, with an additional disadvantage of plaque accumulation and deteriorated hygiene to follow.
WO 01 302 60 A1 to Bergersen discloses a patent application as an intra-oral appliance for repositioning the user's mandible anterior to the user's maxillary teeth, thus opening the user's oral, pharyngeal passageway preventing snoring and sleep apnea. The appliance is two U-shaped shaped plates joined to form a hinge. The lower plate has lingual tabs which are employed to help position the appliance. The main difference from the present patent application is that the device is completely lacking any kind of incrementally adjustability. Also the WO 01 302 60 A1 is merely a transcription of the original patent EP 0 794 749 B1 (Ingemarsson-Matzen & Voss) except the lingual tabs which in the original version is a solid moldable block.
While the above devices represent attempts to solve the snoring and apnea problems, they are all rather complicated in their design and most of these require the interaction of a professional team in their individual design. Furthermore, they are rather discomfortable for the wearer, and they do not appear convincing with respect to their capability of achieving an effective and long-lasting anti-snoring effect.
Thus, there is a demand for a relatively comfortable device which provides a high degree of inhibitory effect on snoring during even long sleeping periods, such as overnight, without adverse effects on the structures involved, and which at the same time is easy and simple to use and wear for normal non-skilled persons. The present invention provides such a device.
The foregoing has outlined some of the more pertinent objects of the present invention. These objects should be construed as being merely illustrative of some of the more prominent features and applications of the invention. Many other beneficial results can be obtained by modifying the invention within the scope of the invention. Accordingly other objects in a full understanding of the invention may be had by referring to the summary of the invention, the detailed description describing the preferred embodiment in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings.